Safety and efficacy of tocilizumab in critically ill patients with COVID-19: an observational study

Abstract

Abstract Background Since the coronavirus disease 2019 (COVID-19) outbreak has rapidly propagated with a high mortality rate, it is currently considered a global emergency. Worldwide, the number of patients with severe acute respiratory syndrome caused by coronavirus 2 is steadily rising. Pneumonia, severe symptoms of acute respiratory distress syndrome (ARDS), and multiple organ failure can all occur in COVID-19 patients. Aim of the work To compare the clinical symptoms and inflammatory markers before and after the administration of 2 doses of tocilizumab, acknowledging that the second dose is given within 24–48 h following the first dose. Patients and methods Baseline CBC with differential, liver function tests, kidney function tests, D dimer, serum ferritin, and CRP were withdrawn. Two doses of tocilizumab were given over 2 days; the first dose was 8 mg/kg diluted in 100 cc saline 0.9% administered over 1 h while the second dose (4 mg/kg diluted in 100 cc saline 0.9%) was given after 24 h. Follow-up inflammatory markers were withdrawn after 3 days following the second dose of tocilizumab. Clinical symptoms were evaluated 48 h following the second dosage of tocilizumab. Oxygen therapy was evaluated on the second and the thirtieth days following tocilizumab administration. Results The administration of tocilizumab highly and significantly improves some clinical symptoms (bony aches, fatigue, fever), oxygen therapy, and PO2/FiO2 ratio. Also, its administration showed no significant effect on the inflammatory markers other than CRP which showed a marked increase. Tocilizumab treatment resulted in worsened expectoration. Tocilizumab showed neither effect on patients’ fate and mortality nor on hospital stay. A mean age of 61 was statistically and highly significant in increased patient mortality. Renal impairment significantly affected the length of hospital stay. The effect of timing of tocilizumab administration on patients’ fate and mortality showed non-statistically significant improvement when given from day 6 to day 10 since the onset of symptoms. Conclusion The administration of tocilizumab highly and significantly improves clinical symptoms, oxygen therapy, and PO2/FiO2 ratio, with no significant effect on inflammatory markers other than CRP which showed a marked increase, which may be attributed to early withdrawal of inflammatory markers. Tocilizumab shows neither the effect on patients’ fate and mortality nor on hospital stay although the mean age of 61 was statistically highly significant on increased patients’ mortality and renal impairment significantly affected length of hospital stay.

Keywords

• Safety efficacy
• Tocilizumab critically
• COVID-19
• Observational study